The present invention relates generally to the design, manufacture and/or selection of biomedical devices, such as implants, drug delivery devices and/or oral dosages, and more particularly, methods and systems for rapid customization of biomedical devices using computing systems and information networks such as the Internet.
A large variety of systems and methods are known for networking computing systems. For example, the World Wide Web (xe2x80x9cthe Webxe2x80x9d) provides an interactive computer environment allowing the exchange of information. The Web uses a collection of common protocols and file formats, including the Hypertext Transfer Protocol (xe2x80x9cHTTPxe2x80x9d), Hypertext Markup Language (xe2x80x9cHTMLxe2x80x9d), SOAP (Simple Object Access Protocol), and XML (extensible Markup Language), to enable users to obtain or exchange information from virtually anywhere in the world, via the Internet. To establish a presence on the Web, organizations construct a xe2x80x9cWeb sitexe2x80x9d which generally includes a collection of documents written in a markup language that is accessible by users using an address on the Web, called a Universal Resource Locator (xe2x80x9cURLxe2x80x9d). Various other networks, such as intranets and/or extranets are also being used as a channel for transmitting information.
Communications networks have proven to be useful for transmitting information for medical applications. Telemedicine typically includes transmitting simple data, remotely monitoring patients"" conditions, transmitting visual information, and even transmitting instructions to remotely operate surgical instruments or medical equipment or to provide other medical instructions in real time. Transmission of visual information is typically for diagnostics purposes, allowing medical conditions to be interpreted by specialists at a distant sites, such as is taught in U.S. Pat. Nos. 6,027,217 and 5,655,084.
Surgery often requires material to replace, repair or augment an anatomical body part. For example, a surgeon may employ materials such as autograft or allograft bone or other implants made from metal, plastic, ceramics or other materials. Proper dimensioning of the material, in both shape and size is important. Ill-fitting implants may be less secure, fail to bond at the mating site, or require replacement. Additionally, cosmetic considerations may be a concern depending on the location of the implant.
In practice, a surgeon may prepare several different sizes of replacement material prior to the operation, selecting the best fitting piece during the operation. The material may be manufactured using conventional manufacturing techniques, such as machining and/or molding. Often the best fitting piece still provides a less than satisfactory fit for medical purposes. Customization of the replacement material is often left solely up to the surgeon, requiring the surgeon to adjust the shape of the material during surgery, for example, by grinding off or removing material from implants or adding filler material such as hydroxyapatite powder. Customizing the implant during the surgery lengthens the surgery, and leads to inconsistent quality, which is dependent on the surgeon""s sculpting skills.
Surgeons may use physical models or prototypes of patient anatomy prior to surgery to help visualize and prepare for the actual procedure. These prototypes typically employ low cost manufacturing techniques, such as molding. Thus, these prototypes are not of a sufficiently high quality to be used in the body, and are generally limited with respect to the variety and types of materials used. Due to manufacturing and other constraints these prototypes omit structures that are desirable in implants, but that are not necessary to the prototype""s intended use in visualization. Thus, these prototypes or physical models are useful only for extra-surgical purposes, such as visualization, practice, planning, and design of templates, and are not intended for use in the body.
Aspects of the present invention provide a method and system of rapid design, manufacture and/or selection of biomedical devices such as implants, oral dosage pills and implantable pharmaceuticals using electronic data and modeling transmissions via computer networks such as the Internet, intranets and/or extranets. Patient information and patient-specific radiological data may be captured and transmitted via a computer network to a design and/or manufacturing site. A multi-dimensional digital model may be created based on the radiological data and patient information. Communications interchanges between a clinical/diagnostic site and a design/manufacturing site permit modification of the digital model until approved. The approved digital model may be converted into machine instructions to construct the biomedical device. Alternatively, the digital model may be employed in a best fit selection a biomedical device from a pre-existing set biomedical devices or pre-existing set of machine-instructions. Transmittal of data over computer networks may be further directed to the use of a Website to perform various client-interaction and follow-up tasks.
One method for rapid construction of biomedical devices may be three dimensional printing. Such technology allows the manufacture of biomedical devices with a great degree of design freedom and complexity as far as dimensional design, and also as far as material composition, porosity, internal architecture, and the like, taking advantage of the information in the digital models. In particular, it may be possible to design active content into the architecture of the implant, such as drugs, DNA, growth factors, comb polymers, and the like, that can direct, promote, or discourage ingrowth of bone, soft tissues, or vascularized tissue in particular places.
Aspects of the invention may increase the responsiveness of the biomedical device preparation and surgical planning process as well as allowing customized construction of the biomedical device. In some aspects, it may be possible to interchange data to design and dimension a biomedical device, to visualize and confirm its suitability, to manufacture it, to deliver the biomedical device to the physician and implant or use the biomedical device in a patient, all within a few days. An increase in responsiveness will have attendant benefits to patient treatment, especially emergency treatment. It may also reduce geographical restrictions on the availability of medical technology.
In a further aspect, rapid design and/or manufacture of custom pharmaceuticals or drugs such as Oral Dosage Forms (ODF); short-run applications to meet small, acute or emergency needs; or individually designed implantable pharmaceuticals or biomedical devices, may be carried out via transmission of data over computer networks.